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FDA 510(k) Application Details - K023824
Device Classification Name
Test, Albumin Cobalt Binding
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510(K) Number
K023824
Device Name
Test, Albumin Cobalt Binding
Applicant
ISCHEMIA TECHNOLOGIES, INC.
4600 WEST 60TH AVE.
ARVADA, CO 80003 US
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PETER CROSBY
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Regulation Number
862.1215
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Classification Product Code
NJV
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Date Received
11/18/2002
Decision Date
02/14/2003
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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